Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage

NCT02678871 | Terminated DMC

• 1 other identifier: 2016-01-18
• Study Type: interventional
• Target: 15
• Locations: 4 countries
• Sites: 6

Brief Summary

Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very challenging in this population of complex and frail subjects. Since the percutaneous left atrial appendage (LAA) closure with the WATCHMAN device proved promising safety and efficacy results in randomized comparisons with OAC (current standard of care), the aim of the current study is to assess the feasibility and the early safety of performing TAVI with the Lotus System and percutaneous LAA closure with the WATCHMAN device at the same session.

Conditions

Aortic Valve Disorder

Keywords

Aortic Valve Stenosis; Left atrial appendage

Outcome Measures

Primary Outcomes (1)

• Early safety (composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days)

  Early safety - composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days. Composite defined as all cause-mortality, all stroke (disabling and non-disabling), life threatening bleeding, acute kidney injury (stage 2 or 3, including renal replacement therapy), coronary artery obstruction requiring intervention, major vascular complications, valve-related dysfunction requiring repeat procedure, pericardial effusion requiring pericardial drainage, and LAA device embolization requiring surgical intervention

  30 Days

Study Arms (1)

All study participants

OTHER

Patients meeting clinical and anatomical pre-requisites will undergo TAVI with the LOTUS or Acurate Neo heart valve system (or subsequent CE marked iterations) and LAA closure with the WATCHMAN device in the same setting. Dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) will be prescribed for 6 months followed acetylsalicylic acid indefinitely. Follow-up will be performed after 1 month, 6 months and 1 year.

Device: Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations); Device: WATCHMAN

Interventions

Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations) DEVICE

Patients meeting clinical and anatomical pre-requisites will undergo TAVI with the Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)

All study participants

WATCHMAN DEVICE

LAA closure with the WATCHMAN device

All study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TAVI candidates
• Elderly patients with symptomatic, severe, calcific, native aortic valve stenosis, assessed by echocardiography AVA up to 1.0 cm2 or AVAi up to 0.6 cm2m2 and mean pressure gradient 40 mmHg or jet velocity 4 ms
• Inoperable or at increased surgical risk (according to multidisciplinary heart team decision)
• Non-valvular AF (paroxysmal, persistent or permanent)
• CHA2DS2-VASc ≥ score
• HAS-BLED score ≥ 2
• Written informed consent
• Aortic annulus size ≥ 20 mm and ≤ 27 mm
• Adequate LAA ostium diameter (17 31mm)

You may not qualify if:

• Previous TAVI
• Previous LAA closure (surgical or percutaneous)
• Previous RF ablation of AF
• Need for long-term OAC (history of pulmonary embolism, mechanical heart valve)
• Contraindication to aspirin
• Relevant CAD requiring revascularization
• Infective endocarditis
• LV ejection fraction \< 20 percent
• Cardiogenic shock or hemodynamic instability
• Symptomatic carotid disease
• Life expectancy \< 1 year
• Severe renal failure (dialysis or serum creatinine level \> 3.0 mg/dl or 265 μmol/L)
• CVE within the past 3 months
• Acute complications occurring during TAVI procedure
• Congenital unicuspid aortic valve

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (6)

Universitätsmedizin Rostock Zentrum für Innere Medizin Abteilung für Kardiologie

Rostock, 18057, Germany

Location

Structural Heart Disease Interventions Unit - IRCCS Policlinico San Donato

San Donato Milanese, Milano, 20097, Italy

Location

Azienda Ospedaliera Universitaria Policlinico "G.Rodolico "

Catania, 95123, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Santa Maria University Hospital,

Lisbon, 1649-028, Portugal

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Lorenz Räber, Prof. Dr.

  Inselspital Bern, Universitätsklinik für Kardiolgie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 10, 2016
• Study Start: March 8, 2017
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); PT (1); DE (1); IT (3)